Dako to Offer New Antibody in U.S. to Diagnose Breast Cancer

Dako has recently received clearance from the U.S. Food and Drug Administration to sell FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor α, Clone EP1 in the United States.

The clone has been available in Europe for some time and has enjoyed widespread acceptance.

“We are very pleased to now be able to supply our customers in the United States with this high-quality antibody for estrogen receptor testing on Dako’s Autostainer Link 48,” said Karen Balstrup, global product manager, IHC Reagents, at Dako.

Research has shown that tumor growth is dependent on the presence of estrogen, progesterone or both in most breast cancers.

Estrogen receptor (ER) status in breast carcinomas is a validated prognostic and predictive factor for managing a patient’s anti-hormonal therapy.

With this important diagnostic tool from Dako, breast cancer patients can be confident they are receiving the most effective treatment for their particular type of breast cancer.

Clone EP1 shows excellent concordance with the existing ER component from Dako’s ER/PR pharmDx Kit, with an overall agreement of 97.7 percent, a strong indication that pathologists can rely on the results obtained from using this antibody.

“Clone EP1 specifically detects nuclear estrogen receptor without cytoplasmic staining and shows a high degree of concordance (greater than 95 percent) to existing clones,” said Sunil S. Badve, M.D., Department of Pathology and Laboratory Medicine, Indiana University.

Badve continued, “Compared with other established ER antibody assays this new clone is a highly sensitive and specific antibody.”

The Monoclonal Rabbit Anti-Human ER α, Clone EP1 was created by Epitomics Inc., using Epitomics’ proprietary rabbit monoclonal antibody technology covered under Patent Nos. 5,675,063 and 7,402,409.

Dako and Epitomics entered into a collaboration in 2011 which allows the companies to unite competencies to provide the anatomic pathology market with antibodies.